R3 71367956Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010599896), received between Nov 13, 2019 and Nov 17, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K123598); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2020Break; Break

  IT WAS REPORTED THAT THE LINER CRACKED AND IS BROKEN. THE FAULT IN THE DEVICE WAS FOUND DURING SERVICE P/M, THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10849916 ↗
• MalfunctionNov 13, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING A THR PROCEDURE, THE SHARP EDGES OF THE TRIAL CUT THE GLOVES OF THE SURGEON. PLASTIC LINER HAD GOUGES. NO DELAY. BACKUP DEVICE AVAILABLE. NO IMPACT OR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9318648 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116